Received Jun 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Stroke; This is a spontaneous report received from a Nurse, Program ID: . A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke". Clinical course: Nurse called on behalf of a family member regarding the Pfizer Covid-19 vaccine if Pfizer had an annual basis for the research that was ongoing or have research division at pfizer because she had not received any information about Pfizer covid vaccine since the beginning and that she can speak with to share her information. She mentioned also inquiring if there was another division of Pfizer for research information that she should know about due to what she was doing on an annual basis for research as sort of a booster, like an identification, she only needs a referral for her to do her work. Also she mentioned that her son had a stroke and thinks it was from the Pfizer covid vaccine. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Based on limited information in the case provided and considering temporal association, there is reasonable possibility of causal association between the event Stroke and the suspect drug BNT162b2 omicron (lp.8.1). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.